Methods for delivering insulin preparations into a lumen of the intestinal tract using a swallowable drug delivery device

Abstract

Embodiments of the invention provide swallowable devices, preparations and methods for delivering drugs and other therapeutic agents within the GI tract. Many embodiments provide a swallowable device for delivering the agents. Particular embodiments provide a swallowable device such as a capsule for delivering drugs into the intestinal wall or other GI lumen. Embodiments also provide various drug preparations that are configured to be contained within the capsule, advanced from the capsule into the intestinal wall and degrade to release the drug into the bloodstream to produce a therapeutic effect. The preparation can be operably coupled to delivery means having a first configuration where the preparation is contained in the capsule and a second configuration where the preparation is advanced out of the capsule into the intestinal wall. Embodiments of the invention are particularly useful for the delivery of drugs which are poorly absorbed, tolerated and/or degraded within the GI tract.

What is claimed is: 
     
       1. A method for delivering insulin to a patient, said method comprising:
 providing an oral solid insulin dosage shaped as a tissue penetrating member having a pointed tip, the tissue penetrating member configured to be carried by a swallowable capsule and penetrate and be inserted into an intestinal wall, wherein upon ingestion the capsule advances to the small intestine of the patient; and 
 delivering the solid insulin dosage into the wall of the small intestine by an application of mechanical force upon a surface of the tissue penetrating member from an actuator operably coupled to the tissue penetrating member wherein upon insertion into the intestinal wall, the tissue penetrating member remains to release insulin into the blood stream from the intestinal wall by degradation of the of the tissue penetrating member. 
 
     
     
       2. A method as in  claim 1 , wherein actuator comprises an expandable member or an expandable balloon. 
     
     
       3. A method as in  claim 1 , wherein the insulin reaches a Cmax in a shorter time period than a time period to achieve a Cmax for an extravascularly injected dose of insulin. 
     
     
       4. A method as in  claim 3 , wherein a tmax for the insulin released from the therapeutic preparation is less than about 50% of a tmax for the extravascularly injected dose of insulin. 
     
     
       5. A method as in  claim 3 , wherein a tmax for the insulin released from the therapeutic preparation is less than about 30% of a tmax for the extravascularly injected dose of insulin. 
     
     
       6. A method as in  claim 3 , wherein a tmax for the insulin released from the preparation is less than about 10% of a tmax for the extravascularly injected dose of insulin. 
     
     
       7. A method as in  claim 1 , wherein the solid dosage insulin comprises a biodegradable material which degrades within the intestinal wall to release insulin into the blood stream. 
     
     
       8. A method as in  claim 7 , wherein the biodegradable material comprises PGLA, a sugar or maltose. 
     
     
       9. A method as in  claim 7 , wherein the solid dosage insulin comprises at least one pharmaceutical excipient. 
     
     
       10. A method as in  claim 9 , wherein the at least one pharmaceutical excipient comprises at least one of a binder, a preservative or a disintegrant. 
     
     
       11. A method as in  claim 10 , wherein the binder comprises PEG. 
     
     
       12. A method as in  claim 1 , wherein a weight per cent of insulin in the solid dosage insulin comprises between about 2 to 15%. 
     
     
       13. A method as in  claim 1 , further comprising retaining the solid dosage within the intestinal wall after insertion. 
     
     
       14. A method as in  claim 1 , wherein the solid dosage insulin produces a long-term release of insulin. 
     
     
       15. A method as in  claim 14 , wherein the solid dosage insulin produces a long-term release of insulin to produce a selectable t½. 
     
     
       16. A method as in  claim 15 , wherein the t½ is about 12 hours. 
     
     
       17. A method as in  claim 1 , wherein the solid dosage insulin carries about 1 to 50 units of insulin. 
     
     
       18. A method as in  claim 17 , wherein the solid dosage insulin carries about 4 to 9 units of insulin. 
     
     
       19. A method as in  claim 1 , wherein the solid dosage insulin further comprises a therapeutically effective dose of an incretin for the treatment of diabetes or a glucose regulation disorder. 
     
     
       20. A method as in  claim 19 , wherein the incretin comprises a glucagon-like peptide-1 (GLP-1), a GLP-1 analogue, exenatide, liraglutide, albiglutide, taspoglutide or a gastric inhibitory polypeptide (GIP). 
     
     
       21. A method as in  claim 20 , wherein the incretin comprises exenatide and the dose is in a range from about 1 to 10 μg. 
     
     
       22. A method as in  claim 20 , wherein the incretin comprises liraglutide and the dose is in a range from about 0.1 to 1 mg.